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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: April 21, 2017

Posted 3 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Cherokee Nation Sues Drug Distributors, Retailers Over Opioid Crisis Six of the top drug distributors and pharmacies in the United States inundated the Cherokee Nation in Oklahoma with hundreds of millions of highly addictive opioid pain pills, according to a lawsuit filed in tribal court. It alleges the...

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The Top 5 Conditions That Shorten Americans' Lives -- And Are Preventable

Posted today in Medical

MONDAY, April 24, 2017 -- More bad news for plus-sized Americans: Obesity is the leading cause of preventable life-years lost in the nation, a new study finds. Obesity steals more years than diabetes, tobacco, high blood pressure and high cholesterol -- the other top preventable health problems that cut Americans' lives short, according to researchers who analyzed 2014 data. "Modifiable behavioral risk factors pose...

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Counting Your Way to Weight Loss

Posted today in Medical

MONDAY, April 24, 2017 -- The concept of counting calories to lose weight is based on a pound of fat being equal to 3,500 calories, so that cutting 500 calories a day means you should lose about one pound a week. That's not always true, however. Many diets limit daily calories to 1,200, but this may not be the magic number for everyone. It could be too low for a very active man or too high for a sedentary woman to...

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Travelers Bring Malaria Back to U.S., With High Costs

Posted today in Medical

MONDAY, April 24, 2017 -- Malaria sickens thousands of Americans and leads to millions of dollars in health care costs each year, a new study finds. Transmission of the mosquito-borne disease in the United States was stamped out decades ago. But it still affects Americans who travel to regions where it remains common, such as Africa, Asia and Latin America, and then bring it back home. Between 2000 and 2014, about...

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Should Prostate Cancer Screening Start Earlier for Black Men?

Posted today in Medical

MONDAY, April 24, 2017 -- With black men at higher risk of developing -- and dying from -- prostate cancer, some researchers believe these men merit their own race-based screening guidelines. It's known that incidence of prostate cancer is 60 percent higher among black men in the United States than among white men, said Ruth Etzioni, senior author of a new study. Moreover, their death rate from prostate cancer is...

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FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

Posted 2 days ago in New Drug Approvals

April 21, 2017 -- FDA today approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must...

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Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL

Posted 6 days ago in New Drug Applications

Basel, April 18, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is the second indication for which...

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FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

Posted 7 days ago in New Drug Approvals

South San Francisco, CA -- April 17, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among ...

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FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer

Posted 7 days ago in New Drug Approvals

South San Francisco, CA -- April 17, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. Tecentriq was previously approved for...

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Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP

Posted 7 days ago in New Drug Applications

SOUTH SAN FRANCISCO, Calif., April 17, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP). "This NDA submission in support of fostamatinib in ITP is a major milestone in bringing new treatment options to...

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FDA Issues Complete Response Letter for Baricitinib

Posted 10 days ago in New Drug Applications

INDIANAPOLIS, April 14, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA). The letter indicates...

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Icon Bioscience Submits NDA For Dexycu, a Potential Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery

Posted 10 days ago in New Drug Applications

Sunnyvale, CA (April 13, 2017) – Icon Bioscience Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the Company’s lead pipeline product Dexycu® (IBI-10090). Supported by data from five...

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Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)

Posted 12 days ago in New Drug Approvals

SAN DIEGO, April 11, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Ingrezza, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults...

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FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

Posted 2 weeks ago in New Drug Approvals

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indications for Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg....

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FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients

Posted 2 weeks ago in Pharma Industry News

April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral...

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FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions

Posted 2 weeks ago in Pharma Industry News

April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or ...

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FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B

Posted 2 weeks ago in New Drug Applications

PLAINSBORO, N.J., April 4, 2017 – Novo Nordisk today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) met to discuss the data submitted to support the Biologics License Application (BLA) for nonacog beta pegol, an investigational glycoPEGylated extended-half-life recombinant factor IX product, for the treatment of hemophilia B. The Committee reviewed the n...

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FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr

Posted 3 weeks ago in Pharma Industry News

March 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The r...

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Monthly News Roundup - March 2017

Posted 3 weeks ago in Pharma Industry News

Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. It is the first treatment approved for primary progressive multiple sclerosis (PPMS); it’s also indicated for relapsing (...

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Monthly News Roundup - February 2017

Posted 7 weeks ago in Pharma Industry News

FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor treatment for adults with type 2 diabetes. This new combination agent is to be used alongside diet and exercise in those without adequate b...

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OncoMed's Phase 2 Trial of Tarextumab in Small Cell Lung Cancer Does Not Meet Endpoints

Posted 7 days ago in Clinical Trials

REDWOOD CITY, Calif., April 17, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today reported top-line results from the company's randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with...

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Genentech Announces Positive Interim Results for Emicizumab in Phase III Study of Children with Hemophilia A

Posted 8 days ago in Clinical Trials

South San Francisco, CA -- April 16, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII. At this interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful...

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FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer

Posted 10 days ago in Clinical Trials

TUCSON, Ariz.--(BUSINESS WIRE)-- April 13, 2017 Nuvox Pharma announces that the FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme (GBM). NVX-108 is an injectable drug that travels through the bloodstream arriving first at the lungs to pick up oxygen and...

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AOBiome Completes Patient Enrollment In Phase 2 Clinical Trial Of Lead Candidate B244 To Treat Elevated Blood Pressure

Posted 10 days ago in Clinical Trials

CAMBRIDGE, Mass., April 13, 2017 /PRNewswire/ -- AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, announced today completion of patient enrollment in the Company's Phase 2 clinical trial of its lead product candidate, designated B244, to treat individuals with elevated blood pressure. The multicenter, randomized,...

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Ohr Pharmaceutical Provides Update on Ongoing Squalamine Clinical Trial in Wet-AMD

Posted 2 weeks ago in Clinical Trials

NEW YORK, April 10, 2017 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced that it plans to amend the ongoing clinical trial investigating Squalamine in wet-AMD (the MAKO Study) to enable efficacy analyses by the end of calendar 2017 or early 2018. The study remains a multi-center, randomized, double-masked, placebo controlled clinical...

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